Home-Based Rehabilitation Training for Chronic Low Back Pain Patients

NCT05998434 | Not Yet Recruiting DMC

• 1 other identifier: [2023]102
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test the effectiveness of a new digital therapy for managing chronic low back pain in adults. The main questions it aims to answer are:

• Does the digital therapy improve back function and reduce pain intensity in participants with chronic low back pain?
• How does the digital therapy's impact compare to traditional exercise therapy? Participants in this study will be asked to use the digital therapy app on their smartphones. They will receive guided core stability exercises through the app and will be encouraged to perform these exercises at home. Researchers will assess participants' progress by monitoring their exercise adherence and tracking changes in their back function and pain intensity over time. To compare the effects of the digital therapy, some participants will follow a traditional exercise therapy program guided by a physical therapist. Researchers will compare the outcomes of these two groups to determine whether the digital therapy is as effective as traditional therapy in improving back function and reducing pain intensity in individuals with chronic low back pain.

Conditions

Chronic Low Back Pain

Keywords

Human Key-Point Detection; Core Stability Exercise; digital healthcare

Outcome Measures

Primary Outcomes (1)

• 11-point numeric rating scale（NRS）

  NRS;0=no pain, 10=unbearable pain

  baseline，4 weeks and 16 weeks

Secondary Outcomes (2)

• the Oswestry Disability Index (ODI)

  baseline，4 weeks and 16 weeks

• The 36-item Short Form Health Survey (SF-36)

  baseline，4 weeks and 16 weeks

Study Arms (2)

the digital therapy

EXPERIMENTAL

The participants randomly assigned to the intervention group will receive home-based exercise training with human key-point detection.They will be instructed to complete a minimum of three sports training sessions per week at their preferred time and location.The exercise prescription will be formulated based on previous comprehensive studies, encompassing exercises targeting strength, balance, flexibility, and mobility.Human key point detection technology accurately estimates 25 key points of the human body in pictures or videos using visual detection.

Behavioral: Improving Low Back Pain Through Motor Control Training

traditional exercise therapy

ACTIVE COMPARATOR

The participants randomly assigned to the control group will receive traditional face-to-face exercise instruction. An experienced therapist( 10 years of experience) will be arranged to provide the subjects with 20-30 minutes of exercise instruction three times a week for four weeks. The training sessions were scheduled to start at 4 p.m. on Monday, Wednesday, and Friday of each week. The exercise training content selected for the control group will be consistent with that of the intervention group.

Behavioral: Improving Low Back Pain Through Motor Control Training

Interventions

Improving Low Back Pain Through Motor Control Training BEHAVIORAL

In the digital healthcare group, participants utilized app-based online motor control training. In contrast, participants in the traditional treatment group underwent motor control training under the guidance of healthcare professionals at the hospital.

the digital therapy; traditional exercise therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years;
• Duration of low back pain of at least 12 weeks;
• Strong willingness to participate in the study and signed informed consent.

You may not qualify if:

• Presence of potential "red flag signs" (e.g., unilateral leg pain and numbness consistent with nerve distribution, intermittent claudication, unexplained sudden weight loss, nocturnal lumbar pain, traumatic lumbago);
• NRS score less than 4 points;
• Regular engagement in core stability training in the past four weeks;
• Inability to independently complete the Chinese electronic questionnaire.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (1)

• Fuming Z, Zhicheng L, Huanjie H, Xinna Z, Rong C, Jiahui P, Liming Y, Xi C, Chuhuai W. Home-based rehabilitation training with human key point detection for chronic low back pain patients: a randomized controlled trial protocol. Trials. 2023 Nov 27;24(1):760. doi: 10.1186/s13063-023-07805-z.

  PMID: 38012740 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share